What the changes say
- Teva faces intensifying competition for growth engines like AUSTEDO, AJOVY, and UZEDY from well-established rivals.
What changed since the prior 10-K
New
- NewRisks related to our ability to successfully compete in the marketplace
which may result in changes to the duration of and criteria for obtaining data and market exclusivity once the new legislation comes into force. See “Item 1—Business—Regulation” for more information
New legislative reforms may alter the duration and criteria for obtaining data and market exclusivity.
- NewRisks related to our ability to successfully compete in the marketplace
Intense competition may adversely affect our ability to successfully develop and commercialize innovative medicines
Intense competition threatens our ability to successfully develop and commercialize innovative medicines ahead of rivals.
- NewRisks related to our ability to successfully compete in the marketplace
may in the future introduce new products or new variations on their existing products, our marketed products, or even those protected by patents, which have in the past and may in the future be replaced in the marketplace or we may be required to lower our prices
Products like AUSTEDO, AJOVY, UZEDY, and COPAXONE face increased market share pressure and pricing competition from new alternatives.
- NewRisks related to our significant indebtedness
specified threshold amount as set forth in each series of senior notes and when sustainability-linked senior notes are outstanding, could lead to an event of default under our senior notes and sustainability-linked senior notes due to cross acceleration provisions
Failure to satisfy financial ratio covenants or threshold amounts on senior notes could trigger cross-acceleration and default.
- NewRisks related to our general business and operations
power outages, network outages, failed upgrades and other events. If our business continuity plans do not effectively resolve such issues on a timely basis, we may suffer significant interruptions in conducting our business, which may adversely impact our business, financial condition and results of operations
Advanced cyber-attacks, potentially enhanced by artificial intelligence, target our networks and third-party service providers.
- NewRisks related to our general business and operations
Our adoption of artificial intelligence (“AI”) technologies introduces new risks and uncertainties
Adopting artificial intelligence technologies introduces risks of inaccuracies, biases, cybersecurity vulnerabilities, and evolving regulatory requirements.
- NewRisks related to compliance, regulation and litigation
State has appealed that injunction, and such legislation still creates a risk of significant potential exposure for settling patent litigations and, in turn, makes it more difficult to settle in the first place, which could have a material adverse effect on our business
Governmental investigations and legal actions regarding pricing and exclusionary practices impact our business and patent settlement processes.
- NewRisks related to compliance, regulation and litigation
We are subject to changes in governmental, investor and societal responses to climate change and sustainability-related issues, which may result in scrutiny or adverse impacts on our business
Evolving societal and investor expectations regarding climate change and sustainability initiatives could lead to criticism or scrutiny.
- NewRisks related to our financial condition
audits, our interpretation of tax legislation may be challenged and tax authorities in various jurisdictions may disagree with, and subsequently challenge, the amount of profits taxed in such jurisdictions under our inter-company agreements
Tax authorities may challenge inter-company profit allocations, and new global minimum tax rules like Pillar Two could impact taxes.
Dropped
- DroppedRisks related to our ability to successfully compete in the marketplace
Our innovative medicines face intense competition from companies that have greater resources and capabilities and we must make significant investments in our pipeline of innovative medicines to address such competition, which may not achieve expected results
- DroppedRisks related to our general business and operations
The widespread outbreak of an illness or any other communicable disease, or any other public health crisis, and the governmental and societal responses thereto, could adversely affect our business, results of operations and financial condition
- DroppedRisks related to our general business and operations
We also rely on complex shipping arrangements to and from the various facilities of our supply chain. Customs clearance and shipping by land, air or sea routes rely on and may be affected by factors that are not in our full control or are hard to predict
- DroppedRisks related to compliance, regulation and litigation
other government purchasers, or other regulatory changes impacting reimbursement or competitive dynamics in multisource markets
- DroppedRisks related to compliance, regulation and litigation
Our business could be negatively impacted by ESG issues
Reworded
- 87% rewrittenRisks related to our financial condition
Our tax liabilities could be larger than anticipated
Trimmed text describing risks related to tax liabilities and inter-company profit challenges by authorities.
- 83% rewrittenRisks related to our financial condition
Failure to maintain effective internal control over financial reporting could have a material adverse effect on our ability to report our financial condition, results of operations, or cash flows accurately and on a timely basis and could harm our reputation
Updated to note that internal control effectiveness is subject to accounting interpretations and estimates like segment reporting changes.
Was: Failure to establish and maintain effective internal control over financial reporting could have a material adverse effect on our ability to report our financial condition, results of operations, or cash flows accurately and on a timely basis and could harm our reputation
- 82% rewrittenRisks related to our general business and operations
Significant disruptions of our information technology systems could adversely affect our business
Added specific mention that IT systems can fail due to poor performance by third-party providers or catastrophic events.
- 61% rewrittenRisks related to our general business and operations
Global economic conditions may negatively affect us and may magnify certain risks that affect our business
Updated macroeconomic commentary with 2025 regional context and added a warning that divergent global regulatory systems increase burdens.
- 60% rewrittenRisks related to our ability to successfully compete in the marketplace
Sales of our generic medicines comprise a significant portion of our business, and we are subject to the significant risks associated with the generic pharmaceutical business
Updated generic revenue figures for 2025, showing $9,421 million or 55% of total revenues compared to 2024 data.
- 59% rewrittenRisks related to compliance, regulation and litigation
The pharmaceutical sector is facing increased government scrutiny from competition and pricing authorities around the world, which may expose us to significant damages and commercial restrictions that can materially and adversely affect our business
Clarified that competition law investigations have resulted in, and may continue to result in, significant liabilities.
- 46% rewrittenRisks related to our ability to successfully compete in the marketplace
If generic or biosimilar products that compete with any of our innovative medicines are approved and sold, sales of our innovative medicines will be adversely affected
Updated examples of innovative medicines facing generic competition from TREANDA to ProAir HFA and QVAR.
- 45% rewrittenRisks related to our significant indebtedness
We have significant debt outstanding, which requires significant interest and principal payments, requires compliance with certain covenants and restricts our ability to incur additional indebtedness or engage in other transactions
Updated consolidated debt figures to $16,807 million as of December 31, 2025, down from $17,783 million.
- 44% rewrittenRisks related to compliance, regulation and litigation
Our operations are subject to complex legal and regulatory environments. If we fail to comply with applicable laws and regulations we may suffer legal consequences that may have a material effect on our business, operations or reputation
- 41% rewrittenRisks related to our general business and operations
Implementation of ongoing optimization efforts may adversely affect our business, financial condition and results of operations
- 35% rewrittenRisks related to compliance, regulation and litigation
Under federal law, companies participating in the Medicaid Drug Rebate program must also participate in the Public Health Service’s 340B drug pricing program. See “Item 1—Business—Regulation” above for more information
Was: Under federal law, companies participating in the Medicaid Drug Rebate program must also participate in the Public Health Service’s 340B drug pricing program. See “Item 1—Business—Regulation” for more information
- 34% rewrittenRisks related to our general business and operations
We have significant operations globally, including in countries that may be adversely affected by political or economic instability, major hostilities or acts of terrorism, which exposes us to risks and challenges associated with conducting business internationally
- 30% rewrittenRisks related to compliance, regulation and litigation
Sanctions and trade control laws create the potential for significant liabilities, penalties and reputational harm
- 29% rewrittenRisks related to our general business and operations
The manufacture of our products is highly complex, and an interruption in our supply chain or problems with internal or third party manufacturing could adversely affect our results of operations
- 28% rewrittenRisks related to compliance, regulation and litigation
We may be susceptible to significant product liability claims that are not covered by insurance
- 28% rewrittenRisks related to our ability to successfully compete in the marketplace
Our revenues and profits from generic products may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy
- 25% rewrittenRisks related to our ability to successfully compete in the marketplace
there is a trend in the innovative medicines industry of seeking to “outsource” drug development by acquiring companies with promising drug candidates and we face substantial competition from historically innovative companies, as well as companies with greater financial resources than us, for such acquisition targets
- 25% rewrittenRisks related to our general business and operations
Our continued success depends on our ability to attract, hire, integrate and retain highly skilled key personnel
- 24% rewrittenRisks related to compliance, regulation and litigation
Our failure to comply with applicable environmental, health and safety laws and regulations worldwide could adversely impact our business and results of operations
- 24% rewrittenRisks related to our financial condition
Fluctuations in exchange rates between the currencies in which we operate in, and the U.S. dollar, may have a material adverse effect on our results of operations, the value of balance sheet items denominated in foreign currencies and our financial condition
- 20% rewrittenRisks related to our ability to successfully compete in the marketplace
We depend on the effectiveness of our patents, confidentiality agreements and other measures to protect our intellectual property rights
- 20% rewrittenRisks related to our ability to successfully compete in the marketplace
We have experienced, and may continue to experience, delays in launches of our new generic products
All 50 risk factors
Headings as the filing states them, in filing order.
Risks related to our ability to successfully compete in the marketplace
- 01Sales of our generic medicines comprise a significant portion of our business, and we are subject to the significant risks associated with the generic pharmaceutical business60% rewritten
- 02Sales of our generic products may be adversely affected by the concentration of our customer base and commercial alliances among our customers
- 03Our revenues and profits from generic products may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy28% rewritten
- 04which may result in changes to the duration of and criteria for obtaining data and market exclusivity once the new legislation comes into force. See “Item 1—Business—Regulation” for more informationNew
- 05We have experienced, and may continue to experience, delays in launches of our new generic products20% rewritten
- 06We may be unable to take advantage of the increasing number of high-value biosimilars opportunities
- 07Intense competition may adversely affect our ability to successfully develop and commercialize innovative medicinesNew
- 08may in the future introduce new products or new variations on their existing products, our marketed products, or even those protected by patents, which have in the past and may in the future be replaced in the marketplace or we may be required to lower our pricesNew
- 09there is a trend in the innovative medicines industry of seeking to “outsource” drug development by acquiring companies with promising drug candidates and we face substantial competition from historically innovative companies, as well as companies with greater financial resources than us, for such acquisition targets25% rewritten
- 10If generic or biosimilar products that compete with any of our innovative medicines are approved and sold, sales of our innovative medicines will be adversely affected46% rewritten
- 11Our success depends on our ability to develop and commercialize additional pharmaceutical products
- 12We depend on the effectiveness of our patents, confidentiality agreements and other measures to protect our intellectual property rights20% rewritten
Risks related to our significant indebtedness
- 13We have significant debt outstanding, which requires significant interest and principal payments, requires compliance with certain covenants and restricts our ability to incur additional indebtedness or engage in other transactions45% rewritten
- 14specified threshold amount as set forth in each series of senior notes and when sustainability-linked senior notes are outstanding, could lead to an event of default under our senior notes and sustainability-linked senior notes due to cross acceleration provisionsNew
- 15We may need to raise additional funds in the future, which may not be available on acceptable terms or at all
Risks related to our general business and operations
- 16Global economic conditions may negatively affect us and may magnify certain risks that affect our business61% rewritten
- 17Implementation of ongoing optimization efforts may adversely affect our business, financial condition and results of operations41% rewritten
- 18Significant disruptions of our information technology systems could adversely affect our business82% rewritten
- 19power outages, network outages, failed upgrades and other events. If our business continuity plans do not effectively resolve such issues on a timely basis, we may suffer significant interruptions in conducting our business, which may adversely impact our business, financial condition and results of operationsNew
- 20Our adoption of artificial intelligence (“AI”) technologies introduces new risks and uncertaintiesNew
- 21A data security breach could adversely affect our business and reputation
- 22The manufacture of our products is highly complex, and an interruption in our supply chain or problems with internal or third party manufacturing could adversely affect our results of operations29% rewritten
- 23We have significant operations globally, including in countries that may be adversely affected by political or economic instability, major hostilities or acts of terrorism, which exposes us to risks and challenges associated with conducting business internationally34% rewritten
- 24Our continued success depends on our ability to attract, hire, integrate and retain highly skilled key personnel25% rewritten
- 25We may not be able to find or successfully bid for suitable acquisition targets or licensing opportunities, or consummate and integrate future acquisitions
- 26We may decide to sell, close or otherwise divest business units, assets or facilities, and any failure to successfully and cost-effectively consummate such divestitures could adversely affect our prospects and opportunities for growth
Risks related to compliance, regulation and litigation
- 27Our operations are subject to complex legal and regulatory environments. If we fail to comply with applicable laws and regulations we may suffer legal consequences that may have a material effect on our business, operations or reputation44% rewritten
- 28Governmental, regulatory and civil proceedings and litigation which we are, or in the future become, party to may have an adverse impact on our business
- 29Healthcare reforms, and related reductions in pharmaceutical pricing, reimbursement and coverage, by governmental authorities and third-party payers may adversely affect our business
- 30Under federal law, companies participating in the Medicaid Drug Rebate program must also participate in the Public Health Service’s 340B drug pricing program. See “Item 1—Business—Regulation” above for more information35% rewritten
- 31Public concern over the abuse of opioid medications, increased legal and regulatory action and the nationwide settlement could negatively affect our business
- 32Additionally, we are defending claims and putative class action lawsuits in Canada in relation to the manufacture, sale, marketing and distribution of opioid medications. The loss or settlement of any such claims related to opioids could have a material adverse impact on our liquidity
- 33The pharmaceutical sector is facing increased government scrutiny from competition and pricing authorities around the world, which may expose us to significant damages and commercial restrictions that can materially and adversely affect our business59% rewritten
- 34State has appealed that injunction, and such legislation still creates a risk of significant potential exposure for settling patent litigations and, in turn, makes it more difficult to settle in the first place, which could have a material adverse effect on our businessNew
- 35We may be susceptible to significant product liability claims that are not covered by insurance28% rewritten
- 36Any failure to comply with the complex reporting and payment obligations under the Medicare and Medicaid programs may result in further litigation or sanctions, in addition to those that we have announced in previous years
- 37Sanctions and trade control laws create the potential for significant liabilities, penalties and reputational harm30% rewritten
- 38Our failure to comply with applicable environmental, health and safety laws and regulations worldwide could adversely impact our business and results of operations24% rewritten
- 39We are subject to changes in governmental, investor and societal responses to climate change and sustainability-related issues, which may result in scrutiny or adverse impacts on our businessNew
Risks related to our financial condition
- 40Because we have substantial international operations, our sales, profits and cash flow may be adversely affected by currency fluctuations and restrictions as well as credit risks
- 41Fluctuations in exchange rates between the currencies in which we operate in, and the U.S. dollar, may have a material adverse effect on our results of operations, the value of balance sheet items denominated in foreign currencies and our financial condition24% rewritten
- 42Our long-lived assets may continue to lead to significant impairments in the future
- 43Our tax liabilities could be larger than anticipated87% rewritten
- 44audits, our interpretation of tax legislation may be challenged and tax authorities in various jurisdictions may disagree with, and subsequently challenge, the amount of profits taxed in such jurisdictions under our inter-company agreementsNew
- 45The termination or expiration of governmental programs or tax benefits, or a change in our business, could adversely affect our overall effective tax rate
- 46Failure to maintain effective internal control over financial reporting could have a material adverse effect on our ability to report our financial condition, results of operations, or cash flows accurately and on a timely basis and could harm our reputation83% rewritten
Risks related to equity ownership
- 47Shareholder rights and responsibilities as a shareholder are governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies
- 48Provisions of Israeli law and our articles of association may delay, prevent or make difficult an acquisition of us, prevent a change of control and negatively impact our share price
- 49Our American Depositary Shares (“ADSs”) and ordinary shares are traded on different stock exchanges and this may result in price variations
- 50It may be difficult to enforce non-Israeli judgments in Israeli courts against us, our officers and our directors
Other TEVA Pharmaceutical Industries 10-Ks
- FY2024 10-K risk factors46 risks
Teva generates significant revenue from generic medicines representing 57.2% of total sales in 2024. Debt stands at $17,783 million requiring substantial interest and principal payments. The company faces heavy competition and patent expirations for innovative drugs like TREANDA.
Filed Feb 05, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.